MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE

Model Number 6131

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator snare was used in the colon to resect a polyp during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the snare was plugged into the generator for energization.The snare was then looped around the polyp and physician stepped on the blue pedal to activate the energy and cauterize the polyp.However, the snare did not deliver energy and no cauterization was made.No visible problem was noted with the cautery pin and handle.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a050702 captures the reportable event of snare loop cutting problems.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18414845
• MDR Text Key: 331704846
• Report Number: 3005099803-2023-06929
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: 08714729019251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6131
• Device Catalogue Number: 6131
• Device Lot Number: 0030732761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1